Drug product
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.
D-0436-2015
Product summary
- Event
- Event 70845
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,816 Bottles
- Official record key
drug-enforcement:D-0436-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Code information: Lot #:18020994, Expiry: October 2015; Lot #: 18021311, Expiry: November 2015.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out of specification